AMRI expands its container closure integrity testing services into EU

Print 26 February 2018
GMP News

AMRI, a global contract research, development and manufacturing organization working with the life sciences industry to improve patient outcomes and quality of life, announced expansion of its industry-leading container closure integrity testing (CCIT) services into the European Union.

The company will build out custom laboratory space for CCIT in its Valladolid, Spain, analytical facility; additional analytical services, including reference standards and ICH stability testing, will follow later in 2018.

Container closure integrity testing (CCIT) is the method for testing the functionality of the primary packaging. Testing is performed in order to determine whether sterile product packaging forms an integral seal during the manufacturing process and maintains that seal over time.

“Within the last several years, the life sciences industry has pivoted toward quantitative methods for integrity testing of sterile package systems, with regulatory agencies increasingly demanding these more modern technologies,” said Mark Stier, head of analytical services at AMRI. “As our client base for this critical service continues to grow in Europe, this expansion is a logical step in our mission to provide comprehensive testing solutions to customers across the globe.”

The expansion of these services to the EU complements the existing local expertise in chromatographic analytical method development and the future build-out of reference standard and ICH stability facilities at the site. Overall, the expansion positions AMRI to provide its complete suite of services to European customers, and deliver a more comprehensive solution for drug discovery, development and manufacturing.

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